BEUDAMED
    FDA Recall Terminated

    iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    Recall: Z-1762-2017 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1762-2017
    Event Number
    76910
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Posted
    April 5, 2017
    Terminated
    June 15, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    Reason

    An error message can occur resulting in the prior studies being unavailable for viewing.

    Action

    The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated 7/11/2016 was issued to nonresponders.

    Distribution

    Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.

    Quantity

    333 sites potentially have the affected versions